Presep
Presep Oximetry Catheter 8.5F 16CM W/O Thromboshield
5manufacturers in China registered for this device type
1catalogue number
11510(k) clearances naming this product code
3recalls on this code
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
Record
| Listed by | Edwards Lifesciences Technology Sarl, United States |
|---|---|
| FDA product code | DXG |
| Device type | Computer, Diagnostic, Pre-Programmed, Single-Function |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1435 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K053609 |
| Record published | 2016-09-03 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: STORE IN A COOL, DRY PLACE. |
| Distribution end date | 2016-11-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| X3816S | Exterior Diameter: 8.5 F (2.8 mm), Usable Length: 16 cm, Number of Lumens: 3, Recommended Guidewire Size: 0.032″ (0.81 mm) | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LiDCO Ltd | Lidco Ltd. | 133 |
| LiDCO | Lidco Ltd. | 32 |
| Transonic | Transonic Systems, Inc. | 31 |
| Computer, Diagnostic, Pre-Programmed, Single-Function | Edwards Lifesciences Technology Sarl | 23 |
| Retia Medical | Retia Medical, LLC | 17 |
| EV1000 | Edwards Lifesciences Technology Sarl | 11 |
| Computer, Diagnostic, Pre-Programmed, Single-Function | GE Healthcare Finland OY | 5 |
| Pediasat | Edwards Lifesciences Technology Sarl | 4 |
| LiDCO | Masimo Corporation | 4 |
| ICU Medical | ICU Medical, Inc | 4 |
| Cnap® Monitor 500 HD | Cnsystems Medizintechnik GmbH | 4 |
| Vigileo | Edwards Lifesciences Technology Sarl | 3 |
Showing 12 of 39. All products under Computer, Diagnostic, Pre-Programmed, Single-Function
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K193179 | 2019-12-17 |
| K131892 | 2014-05-22 |
| K131588 | 2014-05-22 |
| K110597 | 2011-06-14 |
| K103094 | 2011-05-17 |
| K100709 | 2010-12-07 |
| K082308 | 2008-12-09 |
| K062134 | 2006-08-22 |
| K060660 | 2006-04-25 |
| K043103 | 2004-12-09 |
| K040287 | 2004-04-26 |
Recalls Naming This Product
6 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Edwards Lifesciences Technology Sarl | 510(k) number | 2021-07-09 | Class II | Process control | There is a potential for internal leaks within catheters. | 70 UNITS | 2024-01-29 |
| Edwards Lifesciences Technology Sarl | 510(k) number | 2021-07-09 | Class II | Process control | There is a potential for internal leaks within catheters. | 200 UNITS | 2024-01-29 |
| Edwards Lifesciences Technology Sarl | 510(k) number | 2021-07-09 | Class II | Process control | There is a potential for internal leaks within catheters. | 218 UNITS | 2024-01-29 |
| Edwards Lifesciences Technology Sarl | 510(k) number | 2021-07-09 | Class II | Process control | There is a potential for internal leaks within catheters. | 178 units | 2024-01-29 |
| Edwards Lifesciences Technology Sarl | 510(k) number | 2021-07-09 | Class II | Process control | There is a potential for internal leaks within catheters. | 50 units | 2024-01-29 |
| Edwards Lifesciences Technology Sarl | 510(k) number | 2021-07-09 | Class II | Process control | There is a potential for internal leaks within catheters. | 152 units | 2024-01-29 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2010-06-25 | Not classified | Process design | The recall was initiated because the Edwards’ MHANM8 Pressure Slave Cable was wired incorrectly, thus will not work as stated. | 20 units | 2011-05-24 |
| 2008-09-12 | Not classified | Device Design | Edwards Lifesciences has made the decision to initiate a field corrective action for the Edwards Vigilance II Model: Software: versions 00.51, 00.60, 00.61, 00.62, 00.63, 00.64, 00.67, 00.69, 00.71, 00.73 due to the potential of inaccurate | 6934 instruments | 2012-02-08 |
| 2007-05-17 | Not classified | Software design | MAP offset errors: If users are “slaving” mean arterial pressure (MAP) from the bedside monitor into the Vigilance II Monitor for the purpose of the continuous calculation of systemic vascular resistance (SVR), at times, on some bedside mo | 2,680 units in North America distribution | 2009-10-09 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.